Abridged applications are applications where, subject to certain conditions, the applicant is not required to provide the results of pharmacological and toxicological tests or the results of clinical trials. An abridged application can only be lodged with the authority that evaluated and authorised the original product as this authority holds the dossier on the medicinal product, which is essentially similar to that second application. [EMA]
Glossary
Abridged Application
Resources
Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.
Glossary
The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.
Found 371 Results
Page 1 of 2
Page 1 of 2
Page 1 of 2
Page 1 of 2